MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PNEUPAC PARAPAC W/ALARMS; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Catalog Number P200DNJPAMBJP

Device Problems Failure to Deliver (2338); No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2024

Event Type  malfunction  

Event Description

It was reported that it does not start even after switching the power on.There was no patient involvement and no patient harm/adverse event reported.

Manufacturer Narrative

B3: date of event is unknown; no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

H6.Investigation codes: updated.Investigation summary: the affected device was returned for evaluation.No abnormalities in the appearance of the product related to the reported event could be confirmed.Functional test / performance test per s&r procedure.It was confirmed that it did not work even after turning on the switch, confirming the customer's complaint.The root cause is the oscillator does not operate due to leakage from the dump valve, which had come off inside the main unit.The oscillator assembly was replaced to correct the issue.P200dnamb device passed all functional and performance tests after repair.

• Brand Name: PNEUPAC PARAPAC W/ALARMS
• Type of Device: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19060427
• MDR Text Key: 339677645
• Report Number: 3012307300-2024-02257
• Device Sequence Number: 1
• Product Code: BTL
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: P200DNJPAMBJP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/15/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/21/2024
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1